Cleared Traditional

K853728 - KESTREL CONTACT LENS STORAGE CASE(NORYL)
(FDA 510(k) Clearance)

Dec 1985
Decision
98d
Days
Risk

K853728 is an FDA 510(k) clearance for the KESTREL CONTACT LENS STORAGE CASE(NORYL). This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Ryder Intl. Corp. (Arab, US). The FDA issued a Cleared decision on December 13, 1985, 98 days after receiving the submission on September 6, 1985.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K853728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1985
Decision Date December 13, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HPX — Lens, Contact (polymethylmethacrylate)
Device Class

Similar Devices — HPX Lens, Contact (polymethylmethacrylate)

All 73
PMMA CLASIC
K955777 · Rand Scientific Corp. · May 1996
KERATOPLASTY SUTURING LENS
K940106 · Visionary Technologies of Miami, Inc. · May 1994
MULTI-VIEW BIFOCALS
K913081 · Camp Contact Lenses · Oct 1991
MARTIN-HENSLEY SEGMENT LENS
K897021 · Bruce W. Martin O.D. and Edward Hensley · Jun 1990
OPTIKEM PMMA CONTACT LENS
K895411 · Optikem Polymers, Inc. · Feb 1990
ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY
K874591 · Vitreo Dynamics, Co. · May 1988